Comprehensive Monograph on Albiglutide (DB09043)

Executive Summary

Albiglutide is a second-generation, long-acting glucagon-like peptide-1 (GLP-1) receptor agonist developed by GlaxoSmithKline (GSK) for the treatment of type 2 diabetes mellitus (T2DM).[1] Marketed under the brand names Tanzeum in the United States and Eperzan in Europe, it represented a significant molecular engineering effort to overcome the pharmacokinetic limitations of native GLP-1.[2] Its key structural attribute is a recombinant fusion protein composed of a dipeptidyl peptidase-4 (DPP-4)-resistant GLP-1 dimer genetically linked to human albumin.[1] This design successfully conferred an extended terminal half-life of approximately five days, allowing for the convenience of once-weekly subcutaneous administration, a notable improvement over earlier daily or twice-daily agents in its class.[5]

Clinically, Albiglutide demonstrated effective glycemic control as both monotherapy and add-on therapy, significantly reducing HbA1c and fasting plasma glucose levels compared to placebo.[7] The culmination of its clinical development was the Harmony Outcomes trial, a landmark cardiovascular outcomes study that demonstrated Albiglutide's statistical superiority to placebo in reducing the composite of major adverse cardiovascular events (MACE) in a high-risk T2DM population.[9] This finding placed Albiglutide in a select group of antidiabetic agents with proven cardiovascular benefits.